5-year European Clinical Study shows more than 90% Patient and Physician
COPENHAGEN, Denmark, May 5 /PRNewswire/ -- Contura International A/S today announced that 5-year clinical data for its soft volume filler Aquamid(R) was presented at the annual meeting for the American Society of Aesthetic Plastic Surgery (ASAPS) in San Diego. Aquamid(R) is used to rejuvenate or contour the face, either by restoring lost volume or by adding extra volume where needed. Contura is currently conducting a multicenter, comparative clinical trial of Aquamid(R) in the United States.
The 5-year study presented at the ASAPS meeting is a multicenter, prospective study of safety and long-term aesthetic results of Aquamid(R) injections for facial soft tissue augmentation and facial contouring. A total of 116 patients attended the clinics for follow-up five years after their first Aquamid(R) injection. The aesthetic outcome of injections with the Aquamid(R) hydrogel showed that 96% of the 116 patients evaluated after five years had "very good" or "good" aesthetic results according to the physician investigators and 92% of the patients were "very satisfied" or "satisfied". The safety data in the trial showed that injection of Aquamid(R) over a period of 5 years was safe with few and no unexpected adverse events. The 5-year results are consistent with the data from the 1-year, 2-year and 3- to 4-year follow-up visits.
"We are excited that our European 5-year clinical data demonstrates the long-term efficacy and safety of Aquamid(R). Aquamid(R) is well positioned to meet the global consumer needs for long-lasting aesthetic treatments to restore facial volume. In 2008 we expect to complete the 12-month follow-up in our US clinical trial and look forward to submitting the data to the FDA for review," said Michael Peytz, Chief Executive Officer.
Produced using Contura's patented hydrogel technology, Aquamid(R) is composed of 97.5% sterile water and 2.5% cross-linked polyacrylamide. The Aquamid(R) hydrogel is homogeneous: it contains no microparticles; hence its filling effect is due solely to the injected volume. Unlike particle-based fillers, the hydrogel does not rely on an intended foreign body reaction to achieve the desired augmentation. Therefore, the filling effect is immediate and predictable. Moreover, the hydrogel does not cause tissue hardening or fibrosis. No skin test is needed before treatment.
The hydrogel integrates completely into the tissue and does not migrate from the injection site. It stays soft, feels like a natural part of the tissue and follows tissue movements. Because the hydrogel does not degrade over time, it provides augmentation that lasts for years.
Aquamid(R) is available in 40 countries worldwide and is under clinical investigation in the United States. Aquamid is being studied in a double-blind, randomized, multi-center, 2-arm parallel study involving 315 patients in 13 centers comparing the effectiveness of Aquamid(R) and Restylane(R) for the aesthetic treatment of facial wrinkles/folds. Data from this trial will support a PMA application with the FDA.
Aquamid(R) is a soft volume filler that gives a natural look and feel. Produced using Contura's patented hydrogel technology, Aquamid(R) is composed of 97.5% sterile water and 2.5% cross-linked polyacrylamide. Aquamid(R) was approved in Europe in 2001 and is available in 40 countries worldwide. Over 300,000 Aquamid(R) injections have been performed to date. It is currently under clinical investigation in the U.S. for the aesthetic treatment of facial wrinkles/folds. Aquamid(R) is not approved for sale in the United States.
Contura is a medical technology company based in Denmark that develops
and commercializes soft tissue fillers. Contura's products -- Aquamid(R)
for facial contouring and Bulkamid(R) for the treatment of female urinary
incontinence -- are manufactured using the company's patented
polyacrylamide hydrogel technology. Aquamid(R) is sold through a network of
local distributors in 40 countries. Ethicon Inc., a Johnson & Johnson
company, holds the exclusive worldwide distribution rights for Bulkamid and
has started to sell the product in Europe. Clinical trials evaluating
Aquamid(R) and Bulkamid(R) are ongoing in the United States. Data from
these trials will be used to support PMA applications for these products.
Contura's products are developed, manufactured and tested in Denmark in
compliance with the European regulatory requirements for medical devices.
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